Cost-Effectiveness of Fractional Flow Reserve–Guided Treatment for Acute Myocardial Infarction and Multivessel Disease: A Prespecified Analysis of the FRAME-AMI Randomized Clinical Trial.

Hong, David; Lee, Seung Hun; Lee, Jin; Lee, Hankil; Shin, Doosup; Kim, Hyun Kuk; Park, Keun Ho; Choo, Eun Ho; Kim, Chan Joon; Kim, Min Chul; Hong, Young Joon; Jeong, Myung Ho; Ahn, Sung Gyun; Doh, Joon-Hyung; Lee, Sang Yeub; Don Park, Sang; Lee, Hyun-Jong; Kang, Min Gyu; Koh, Jin-Sin; Cho, Yun-Kyeong

Key Points: Question: Is fractional flow reserve (FFR)–guided treatment for non–infarct-related artery (IRA) percutaneous coronary intervention (PCI) more cost-effective than angiography-guided treatment for patients with acute myocardial infarction and multivessel disease? Findings: In this prespecified analysis of the FRAME-AMI randomized clinical trial with 562 patients, FFR-guided PCI increased quality-adjusted life-years by 0.06 and decreased the total cumulative cost per patient (in US dollars) by $1208 compared with angiography-guided PCI. The incremental cost-effectiveness ratio was −$19 484 and the incremental net monetary benefit was $3378. Meaning: This study found that FFR–guided PCI for non-IRA lesions saved medical costs and increased quality of life better than angiography-guided PCI in patients with acute myocardial infarction and multivessel disease. This prespecified analysis of a randomized clinical trial evaluates the cost-effectiveness of fractional flow reserve–guided vs angiography-guided percutaneous coronary intervention for patients with acute myocardial infarction and multivessel disease. Importance: Complete revascularization by non–infarct-related artery (IRA) percutaneous coronary intervention (PCI) in patients with acute myocardial infarction is standard practice to improve patient prognosis. However, it is unclear whether a fractional flow reserve (FFR)–guided or angiography-guided treatment strategy for non-IRA PCI would be more cost-effective. Objective: To evaluate the cost-effectiveness of FFR-guided compared with angiography-guided PCI in patients with acute myocardial infarction and multivessel disease. Design, Setting, and Participants: In this prespecified cost-effectiveness analysis of the FRAME-AMI randomized clinical trial, patients were randomly allocated to either FFR-guided or angiography-guided PCI for non-IRA lesions between August 19, 2016, and December 24, 2020. Patients were aged 19 years or older, had ST-segment elevation myocardial infarction (STEMI) or non-STEMI and underwent successful primary or urgent PCI, and had at least 1 non-IRA lesion (diameter stenosis >50% in a major epicardial coronary artery or major side branch with a vessel diameter of ≥2.0 mm). Data analysis was performed on August 27, 2023. Intervention: Fractional flow reserve–guided vs angiography-guided PCI for non-IRA lesions. Main Outcomes and Measures: The model simulated death, myocardial infarction, and repeat revascularization. Future medical costs and benefits were discounted by 4.5% per year. The main outcomes were quality-adjusted life-years (QALYs), direct medical costs, incremental cost-effectiveness ratio (ICER), and incremental net monetary benefit (INB) of FFR-guided PCI compared with angiography-guided PCI. State-transition Markov models were applied to the Korean, US, and European health care systems using medical cost (presented in US dollars), utilities data, and transition probabilities from meta-analysis of previous trials. Results: The FRAME-AMI trial randomized 562 patients, with a mean (SD) age of 63.3 (11.4) years. Most patients were men (474 [84.3%]). Fractional flow reserve–guided PCI increased QALYs by 0.06 compared with angiography-guided PCI. The total cumulative cost per patient was estimated as $1208 less for FFR-guided compared with angiography-guided PCI. The ICER was −$19 484 and the INB was $3378, indicating that FFR-guided PCI was more cost-effective for patients with acute myocardial infarction and multivessel disease. Probabilistic sensitivity analysis showed consistent results and the likelihood iteration of cost-effectiveness in FFR-guided PCI was 97%. When transition probabilities from the pairwise meta-analysis of the FLOWER-MI and FRAME-AMI trials were used, FFR-guided PCI was more cost-effective than angiography-guided PCI in the Korean, US, and European health care systems, with an INB of $3910, $8557, and $2210, respectively. In probabilistic sensitivity analysis, the likelihood iteration of cost-effectiveness with FFR-guided PCI was 85%, 82%, and 31% for the Korean, US, and European health care systems, respectively. Conclusions and Relevance: This cost-effectiveness analysis suggests that FFR-guided PCI for non-IRA lesions saved medical costs and increased quality of life better than angiography-guided PCI for patients with acute myocardial infarction and multivessel disease. Fractional flow reserve–guided PCI should be considered in determining the treatment strategy for non-IRA stenoses in these patients. Trial Registration: ClinicalTrials.gov Identifier: NCT02715518

UNITED States; EUROPE; SOUTH Korea; PERCUTANEOUS coronary intervention; MYOCARDIAL infarction; CORONARY circulation; TREATMENT effectiveness; RANDOMIZED controlled trials; ST elevation myocardial infarction; COST effectiveness; CORONARY artery disease; DESCRIPTIVE statistics; RESEARCH funding; ANGIOGRAPHY; STATISTICAL sampling; QUALITY-adjusted life years

JAMA Network Open, 2024, Vol 7, Issue 1, pe2352427

2574-3805

Academic Journal

10.1001/jamanetworkopen.2023.52427